Initiate Phase III CT: CDSCO panel tells Eris Lifesciences for FDC Gliclazide, Sitagliptin
New Delhi: Based on the bioequivalence (BE) report submitted by the drug major Eris Lifesciences, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended to initiate the Phase III clinical trial (CT) of the antidiabetic fixed-dose combination Gliclazide sustained released (SR) 30mg/60mg plus Sitagliptin 100mg/100mg tablets.
This came after the firm presented the bioequivalence (BE) report of the Gliclazide SR 30mg/60mg plus Sitagliptin 100mg/100mg tablets before the committee.
Gliclazide is a sulfonylurea used to treat hyperglycemia in patients with type 2 diabetes mellitus. Gliclazide binds to the β cell sulfonylurea receptor (SUR1). This binding subsequently blocks the ATP-sensitive potassium channels. The binding results in the closure of the channels and lead to a resulting decrease in potassium efflux leading to depolarization of the β cells. This opens voltage-dependent calcium channels in the β cell resulting in calmodulin activation, which in turn leads to exocytosis of insulin-containing secretory granules.
Sitagliptin is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. Sitagliptin increases insulin production and decreases hepatic glucose overproduction. Sitagliptin prolongs the action of GLP-1 and GIP. By enhancing active incretin levels, sitagliptin increases insulin production and lowers glucagon secretion from alpha cells, which decreases hepatic glucose overproduction.
At the recent SEC meeting for the Endocrinology & Metabolism held on the 16th & 17th of February 2023, the expert panel reviewed the BE report of the FDC Gliclazide SR 30mg/60mg plus Sitagliptin 100mg/100mg tablets.
After detailed deliberation, the committee recommended to consider the BE report and to initiate the Phase III clinical trial study.
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